Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

Not Applicable

Terminated

• Conditions: Pain, Postoperative; Knee Replacement, Total; Functional Independence

• Registration Number: NCT05490186
• Lead Sponsor: North York General Hospital

Brief Summary

There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-16
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• undergoing unilateral TKR for the treatment of osteoarthritis
• between the age of 18 and 85 years of age
• able to read, speak and understand English, have a telephone
• are able to provide consent

Exclusion Criteria

• enrolled in another study, are
• undergoing revision surgery or bilateral surgery, and are
• over the age of 85 years. Patients will also be excluded if they
• have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Function	post-operatively 1 year	Oxford knee score

Secondary Outcome Measures

Name	Time	Method
Function	post-operatively at 2 years	Oxford knee score
Pain intensity and effectiveness of analgesics	Post-operatively at 2 years	Brief Pain Inventory-Short Form - Pain Severity Index
Quality of Life following knee surgery	post-operatively at 1 year	EuroQol 5D index
Satisfaction with knee surgery	Post-operatively at 2 years	Forgotten Joint Score

Trial Locations

Locations (1)

North York General Hospital; 🇨🇦 Toronto, Ontario, Canada